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    특허신약의 가격통제 및 공급 정책으로서의 강제실시 : 한국에서의 가능성과 한계 = Compulsory Licensing as a price control and supply policy of patented drugs : Is it a possible alternative in South Korea?

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    https://www.riss.kr/link?id=A104442386

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    다국어 초록 (Multilingual Abstract) kakao i 다국어 번역

    Korea has had problems with the price and supply of essential drugs such as Gleevec for leukemia , Fuzeon for HIV/AIDS, and Tamiflu for both avian flu and swine flu. The shortage or refusal of patented drugs supply is imposing a heavy burden in not only developing countries but also developed countries. Thinking over the serious results, we need to concern about the limited access to patented drugs by multinational drug companies' patent monopoly especially for pandemic and life threatening diseases. The effective response regarding to pandemicand life threatening diseases. The effective response regarding to pandemic situation requests collaborative and unbiased provisions of all countries in the world, however, sometimes patent monopoly may hinder the efforts.
    Compulsory licensing has been considered to be a useful alternative to the abuse of patent rights. However, the Korean experiences of compulsory licensing have left some controversial issues in connection with the availability of it in Korea.
    ‘Flexibility’ allowed in TRIPS and Doha Declaration has not come into effect in Korea for several reasons. Although the situation shows the limitations of compulsory licensing as a pharmaceutical supply policy, it is clear that compulsory licensing still has the possibilities of enhancing the access to medicines of all countries in need. Through searching the institutionalization process and experiments of compulsory licensing in Korea, this article explores the possibilities and the limits.
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    Korea has had problems with the price and supply of essential drugs such as Gleevec for leukemia , Fuzeon for HIV/AIDS, and Tamiflu for both avian flu and swine flu. The shortage or refusal of patented drugs supply is imposing a heavy burden in not on...

    Korea has had problems with the price and supply of essential drugs such as Gleevec for leukemia , Fuzeon for HIV/AIDS, and Tamiflu for both avian flu and swine flu. The shortage or refusal of patented drugs supply is imposing a heavy burden in not only developing countries but also developed countries. Thinking over the serious results, we need to concern about the limited access to patented drugs by multinational drug companies' patent monopoly especially for pandemic and life threatening diseases. The effective response regarding to pandemicand life threatening diseases. The effective response regarding to pandemic situation requests collaborative and unbiased provisions of all countries in the world, however, sometimes patent monopoly may hinder the efforts.
    Compulsory licensing has been considered to be a useful alternative to the abuse of patent rights. However, the Korean experiences of compulsory licensing have left some controversial issues in connection with the availability of it in Korea.
    ‘Flexibility’ allowed in TRIPS and Doha Declaration has not come into effect in Korea for several reasons. Although the situation shows the limitations of compulsory licensing as a pharmaceutical supply policy, it is clear that compulsory licensing still has the possibilities of enhancing the access to medicines of all countries in need. Through searching the institutionalization process and experiments of compulsory licensing in Korea, this article explores the possibilities and the limits.

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    참고문헌 (Reference)

    1 육소영, "특허법상 강제실시권의 연구" 16 (16): 117-140, 2005

    2 이익희, "특허발명의 강제실시제도 공중보건문제 : 해결을 위한 제도개선을 중심으로" 특허청 2005

    3 김남규, "특허발명의 강제실시제도 -의약품 접근권 향상을 위한 제도개선을 중심으로-" 한국법정책학회 (2(6)) : 805-824, 2006

    4 남희섭, "특허발명의 강제실시"

    5 오준병, "특허권 강화와 기술혁신에 관한 실증연구: 우리나라의 제 11차 특허법 개혁을 중심으로" 한국경제학회 56 (56): 63-90, 2008

    6 서환주, "특허권 강화는 기술혁신을 촉진하는가? 한국의 특허법 개혁을 중심으로" 한국국제경제학회 10 (10): 183-216, 2004

    7 김홍국, "조류독감약‘강제실시권’검토"

    8 한국보건산업진흥원, "제약산업 실태분석" 2008

    9 이영수, "제약사 비싼 약값 요구, 약가협상 결렬 원인" 국민일보 쿠키뉴스

    10 양희진, "자유무역협정과 지적재산권 강화, 어떻게 대응할 것인가" 23 (23): 01-123, 2005

    1 육소영, "특허법상 강제실시권의 연구" 16 (16): 117-140, 2005

    2 이익희, "특허발명의 강제실시제도 공중보건문제 : 해결을 위한 제도개선을 중심으로" 특허청 2005

    3 김남규, "특허발명의 강제실시제도 -의약품 접근권 향상을 위한 제도개선을 중심으로-" 한국법정책학회 (2(6)) : 805-824, 2006

    4 남희섭, "특허발명의 강제실시"

    5 오준병, "특허권 강화와 기술혁신에 관한 실증연구: 우리나라의 제 11차 특허법 개혁을 중심으로" 한국경제학회 56 (56): 63-90, 2008

    6 서환주, "특허권 강화는 기술혁신을 촉진하는가? 한국의 특허법 개혁을 중심으로" 한국국제경제학회 10 (10): 183-216, 2004

    7 김홍국, "조류독감약‘강제실시권’검토"

    8 한국보건산업진흥원, "제약산업 실태분석" 2008

    9 이영수, "제약사 비싼 약값 요구, 약가협상 결렬 원인" 국민일보 쿠키뉴스

    10 양희진, "자유무역협정과 지적재산권 강화, 어떻게 대응할 것인가" 23 (23): 01-123, 2005

    11 배은영, "의약품 등재가 결정방식 및 개선방안 연구" 건강보험심사평가원 2008

    12 배은영, "약제비 증가의 기여 요인과 영향 분석" 한국보건경제정책학회 13 (13): 39-54, 2007

    13 이준규, "신종플루 치료제‘타미플루’복제품 국내 생산하게 해야"

    14 안영진, "식약청, 인체감염 조류독감 비상땐 타미플루 카피약 생산 고려"

    15 이수연, "다국적 제약자본의 지적재산권 보호 對 국민 건강권 보장간의 갈등" 한국사회복지연구회 (23) : 139-167, 2004

    16 보건복지부, "국민건강보험 요양급여의 기준에 관한 규칙 일부개정령(안) 및 신의료기술 등의결정 및 조정기준 개정(안) 입법예고"

    17 남희섭, "공공의 이익을 위한 특허발명의 강제실시" 30 : 77-108, 2003

    18 Van Overwalle G, "eshaping Belgian Patent Law : The Revision of the Research Exemption and the Introduction of a Compulsory License for Public Health"

    19 Thomas C, "Trade policy and the politics of access to drugs" 23 (23): 251-264, 2002

    20 Chaudhuri S, "The WTO and India's Pharmaceuticals Industry : Patent Protection,Trips, and Developing Countries" Oxford University Press 2005

    21 Permanand G, "The Politics of Pharmaceuticals in the European Union" Open University Press 40-51, 2004

    22 Pugatch MP, "The International Political Economy of Intellectual Property Rights" 129-, 2004

    23 Danzon PM, "The Impact of Price Regulation on the Launch Delay of New Drugs - Evidence from Twenty-five Major Markets in the 1990s" 14 : 269-292, 2005

    24 Cahoy DR, "The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach" 45 (45): 299-300, 2008

    25 Abott FM, Reichman JH, "The Doha Round's Public Health Legacy : Strategies for the Production and Diffusion of Patented Medicines under the Amended TRIPS Provisions" 10 (10): 921-987, 2007

    26 강희갑, "TRIPS 협정의 의약품 특허와 공중보건논의에 관한 미국의 입장과 대응방안" 한국산업재산권법학회 (20) : 79-108, 2006

    27 Cugno F, "Static Efficiency of Compulsory Licensing: Price Vs"

    28 Wright T, "Roche Plans Big Increase in Tamiflu Production"

    29 NIHCM Foundation, "Prescription Drugs & IPP"

    30 Berndt ER, "Pharmaceuticals in U.S. health care : Determinants of quantity and price" 16 : 45-66, 2002

    31 Paris V, "Pharmaceutical Pricing and Reimbursement Policies in Canada"

    32 Organisation for Economic Co-operation and Development(OECD), "Pharmaceutical Pricing Policies in a Global Market"

    33 Lee KW, "Permitted use of patented inventions in the United States : Why Prescription drugs do not merit compulsory Licensing" 4 : 808-820, 2006

    34 Ho CM, "Patent Breaking or Balancing? Separating Strands of Fact from Fiction Under TRIPS" 34 (34): 371-470, 2009

    35 "International Trade Administration"

    36 Drahos P, "Intellectual property, corporate strategy, globalisation : TRIPS in context" 20 (20): 451-480, 2002

    37 Werhane PH, "Intellectual property rights, moral imagination, and access to life-enhancing drugs" 15 (15): 595-613, 2005

    38 Sell SK, "Intellectual Property Rights in Governing Globalization : Power, authority and Global Governance" Blackwell Publishers 171-188, 2002

    39 Commission on Intellectual Property Rights(CIPR), "Integrating Intellectual Property Rights and Development Policy"

    40 Yeh BT, "Influenza Antiviral Drugs and Patent Law Issues" 2005

    41 Bale HE Jr, "Industry, innovation and social values" 11 (11): 31-40, 2005

    42 Light DW, "In the name of research: Raising drug prices here and abroad 15 Dec"

    43 Azra J, "How Can State Provide Affordable Pharmaceuticals to the Underserved?" 17 (17): 808-820, 2006

    44 "Health Intervention and Technology Assessment Program(HITAP)" 2008

    45 Drahos P, "Global Property Rights in Information : The story of TRIPS at the GATT" 13 (13): 6-19, 1995

    46 Arndt HW, "GATT and the developing world : Agenda for a new trade round" 123 (123): 705-718, 1987

    47 Putnam R, "Diplomacy and Domestic Politics, International organization : The Logic of Two-Level Games" 42 (42): 427-460, 1988

    48 Bird RC, "Defending Intellectual Property Rights in the BRIC Economies" 43 (43): 317-363, 2006

    49 World Trade Organization(WTO), "Declaration on the TRIPS agreement and public health, Adopted on 14 November 2001"

    50 World Trade Organization(WTO) Website, "Compulsory licensing"

    51 Reichman JH, "Compulsory Licensing of Patented Pharmaceutical Inventions:Evaluating the Options" 37 (37): 247-263, 2009

    52 Lybecker KM, "Compulsory Licensing in Canada and Thailand:Comparing Regimes to Ensure Legitimate Use of the WTO Rules" 37 (37): 222-240, 2009

    53 Moser P, "Compulsory Licensing Evidence from the Trading with the Enemy Act.Stanford University Department of Economics 2008-2009 seminar series"

    54 Cohen J, "Comparing Patient Access to Pharmaceuticals in the UK and US" 5 (5): 177-187, 2006

    55 Chien C, "Cheap Drugs at What Price to Innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation?" 8 : 853-908, 2003

    56 Russell S, "Bird flu drug maker won't share patent"

    57 Nishimura M, "Analysis of the Political Processes for the Formation of the TRIPs Agreement : With the Focus on the Pharmaceutical Industry and the Computer Industry in Japan, Europe, and the United States"

    58 World Trade Organization(WTO), "Agreement on Trade-Related Aspects of Intellectual Property Rights"

    59 정명진, "2008년 의약품산업 분석보고서" 한국보건산업진흥원 2008

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